Prasterone, DHEA tablets or capsules

What is this medicine?

PRASTERONE (also known as DHEA), is similar to a hormone produced in the body. It is often used as a dietary supplement. The FDA has not approved this supplement for any medical use.

How should I use this medicine?

Take this medicine by mouth with a glass of water. Follow the directions on the prescription label. Take your medicine at regular intervals. Do not take your medicine more often than directed. Do not stop taking except on your doctor's advice.

Talk to your pediatrician regarding the use of this medicine in children. This medicine is not approved for use in children.

What side effects may I notice from receiving this medicine?

Side effects that you should report to your doctor or health care professional as soon as possible:

acne

breast pain, swelling, or change in breast appearance

trouble passing urine or change in the amount of urine

dark urine

general ill feeling or flu-like symptoms

hair growth in unusual places

hoarseness of the voice

light-colored stools

nausea, vomiting

menstrual changes

right upper belly pain

unusually weak or tired

yellowing of the eyes or skin

Side effects that usually do not require medical attention (report to your doctor or health care professional if they continue or are bothersome):

change in sex drive or performance

headache

loss of appetite

What may interact with this medicine?

Do not take this medicine with any of the following medications:

dietary supplements containing DHEA

This medicine may also interact with the following medications:

alprazolam

aspirin

cilostazol

clopidogrel

male hormones (such as methyltestosterone or testosterone)

female hormones, like estrogens or progestins and birth control pills, patches, rings, or injections

fertility treatments (such as clomiphene, or fertility injections)

leuprolide

medicines for diabetes

medicines for sleep

saw palmetto

steroid medicines like prednisone or cortisone

ticlopidine

warfarin

What if I miss a dose?

If you miss a dose, take it as soon as you can. If it is almost time for your next dose, take only that dose. Do not take double or extra doses.

Where should I keep my medicine?

What should I tell my health care provider before I take this medicine?

They need to know if you have any of these conditions:

breast cancer (men or women)

cancer of the lining of the uterus (endometrial cancer)

diabetes or high blood sugar

immune system problems

infertility

liver disease

post-menopause

prostate cancer or an enlarged prostate gland

rheumatoid arthritis

uterine cancer

vaginal bleeding or menstrual problems

vaginal cancer

an unusual or allergic reaction to Prasterone, DHEA, soy, other medicines, foods, dyes, or preservatives

pregnant or trying to get pregnant

breast-feeding

What should I watch for while using this medicine?

Visit your doctor or health care professional for regular checks on your progress. Tell your doctor or healthcare professional if your symptoms do not start to get better or if they get worse.

Women should inform their doctor if they wish to become pregnant or think they might be pregnant. There is a potential for serious side effects to an unborn child. Talk to your health care professional or pharmacist for more information.

DHEA use is banned in competitive sports. Both college (NCAA) and olympic (USOC) committees do not allow DHEA use among athletes.

Supplements are not regulated like medicines. Rigid quality control standards are not required for dietary supplements. The purity and strength of these products can vary. The safety and effect of this dietary supplement for a certain disease or illness is not well known. This product is not intended to diagnose, treat, cure or prevent any disease.

The Food and Drug Administration suggests the following to help consumers protect themselves:

Always read product labels and follow directions.

Natural does not mean a product is safe for humans to take.

Look for products that include USP after the ingredient name. This means that the manufacturer followed the standards of the US Pharmacopoeia.

Supplements made or sold by a nationally known food or drug company are more likely to be made under tight controls. You can write to the company for more information about how the product was made.